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Reporting risks

In order to be able to identify risks associated with medicinal products as quickly as possible, the BfArM is dependent on reliable data and warning signs from practical experience. According to their professional code of conduct, all physicians are obligated to report adverse drug reactions, including suspected cases, either to the Drug Commission of the German Medical Association or to the BfArM. Especially suspected adverse drug reactions reported within the spontaneous reporting system play a crucial role. The sooner, more frequently, and in more detail the Federal Institute receives these reports (e.g. from physicians), the earlier warning signs can be detected and evaluated in order to take the necessary measures to protect the patients.

Should you have observed an adverse drug reaction which you wish to report in writing, you will find the corresponding (online) form on the homepage. For its evaluation, the BfArM needs as detailed medical information as possible. Patients are therefore kindly requested to make the report in cooperation with a physician of their trust.

Medicinal products are generally produced and marketed on a multinational level. If counterfeits, batch recalls, or quality defects in connection with medicinal products become known in Germany, the BfArM is obligated to inform the authorities of the other EU Member States accordingly. For this purpose, an international Rapid Alert System was introduced. The BfArM receives the relevant information from the competent authorities of the "Länder" by way of a corresponding form which can be downloaded from homepage.

The European Medicines Agency also provides a database on suspected adverse drug reactions. These suspected cases relate to those medicinal products that are licensed in the European Economic Area (EEA). The reports are entered electronically into the EudraVigilance system by the national medicines regulatory authorities and the pharmaceutical entrepreneurs who hold the marketing authorisations for the medicinal products. EudraVigilance was introduced for the collection of reports of suspected cases of side effects. These reports are considered for the evaluation of benefits and risks of medicinal products during their development as well as for monitoring their safety after marketing authorisation in the European Economic Area. The system was launched in December 2001.